5.2.1. Transmission Report

5.2.1.1. Overview

The data retrieved from the pacemakers communicating only with inductive wand are checked, analyzed and presented in a report for review by the patient’s following physician.

The transmission report has been designed to provide a synthesized view of the main technical and diagnostic data in order to evaluate the functioning status of the implanted cardiac device and the patient's health condition.

The transmission report is provided as a PDF on the website on the ALL NEW TRANSMISSIONS or NEW FOLLOW-UPS pages and can be printed. You can also export the report in PDF onto your computer, using the Save icon available in Acrobat Reader or select Save a Copy from the File drop-down menu. Browse the possible locations on your PC or the network where you can save a copy of a document. Click on the Save button.

5.2.1.2. Header

The header provides patient and device information:

• patient's name and date of birth 
• current device implant date
• device family, model and serial number

5.2.1.3. Footer

The footer provides the following information:

• the date and time the transmission is sent
• the confidential patient information statement
• page number over total number of pages
• report software version
• implanted device software version

5.2.1.4. Title of Report

The title provides the following information:

• Interrogation date: date of transmission from the implanted device to the monitor
• Interrogation time: time of transmission from the implanted device to the monitor
• Last reset date: Date corresponding to the last reset of memory in the implanted device.

5.2.1.5. Programmed parameters

This section provides the value of the following brady parameters:

• Pacing mode
• Basic rate
• Max Rate
• AV delay at rest and in exercise
• AV delay offset
• VV delay
• Atrial and Ventricular sensitivity
• Atrial and Ventricular lead sensing polarity
• Atrial and Ventricular pacing amplitude
• Atrial and Ventricular pacing pulse width
• Atrial and Ventricular pacing polarity
• MRI mode

5.2.1.6. Warnings

The warning section highlights specific findings that are considered critical for the proper functioning of the device and for the patient. The data retrieved from the implanted device are screened to automatically detect conditions outside of pre-defined parameter boundaries. When an event occurs that meets the alert conditions, a warning is displayed.

If no warning conditions are detected, the section will display the message: "No warning detected".

If the list of messages is too long, the list is truncated and indicates the total number of warnings.

5.2.1.7. Leads

Overview color indicator:

Lead status is evaluated comparing the impedance measurement performed to a predefined range (values between 200 ohms and 3000 ohms). Lead status is displayed according to the color codes described below. The warning section will display a specific message when more information is available.

• OK: normal lead impedance conditions. Impedance for all leads is measured within normal range (values between 200 ohms and 3000 ohms).
• Red: The last impedance measurement of at least one of the leads is out of the predefined range (200 ohms-3000 ohms). Look at the impedance measurements to see which leads are concerned.
• Unknown: This status is displayed if there are no data available to evaluate the lead condition: for instance no lead impedance measurement was performed since last reset of the implanted device memories.

The table provides the main information related to each lead:

• Impedance (ohms): the last impedance measurements (performed every six hours) for each lead:
  • A
  • RV
  • LV
• Detection (mV): the last endocardial wave amplitude measurements in millivolts:
  • P wave amplitude for atrial channel
  • R wave amplitude for right ventricular channel
• Threshold (V): Pacing Threshold values stored in the implanted device (in Volts):
  • Atrial: Last manual Pacing Threshold executed with the programmer or last Automatic Threshold executed by the device if RAAT algorithm is active.
  • Right Ventricular: Last manual Pacing Threshold executed with the programmer or last Automatic Threshold executed by the device if RVAT algorithm is active.
  • Left Ventricular: Last manual Pacing Threshold executed with the programmer.

For each display:

• The measurement date is added when available
• For impedance measurement out of the programmed normal range (200 – 3000 ohms), the value is highlighted “≤200” or “>3000 ohms”

Impedance graphs for each lead:

• Impedance: 6 month trend of the lead impedance plotted by the daily mean value

5.2.1.8. Battery

Overview color indicator:

• OK: normal. The battery measurements display values within normal range.
• Red: indicates Recommended Replacement Time (RRT)* condition has been reached.

The indicator will display a message “<3 months” or “<12 months” when the remaining longevity can be calculated and is close to the Recommended Replacement Time.

*: corresponds to previously used Elective Replacement Indicator (ERI).

Battery information:

• Last Battery impedance measurement used by the device to estimate time to RRT
• Time to RRT: estimated time to reach the Recommended Replacement Time.
• Battery curve: battery impedance over time

5.2.1.9. Sensing

The table presents brady therapy statistics since the last reset:

• For each Lead:
  • Percentage of pacing in Rate Response (RR)
  • Percentage of pacing (Pace)
  • Percentage of sensing (Sens.)
  • Percentage of PAC/PVC
• Mode switch activity:
  • Number of Mode Switches
  • Total Time in Mode Switch
• P Wave Amplitude Distribution
  • Two histograms report the distribution of atrial wave amplitude measured beat to beat.
  • Graphs report the total number of cycles counted and the programmed sensitivity (red bar) for the Atrial channel:
    • Sinus P waves: recorded since last reset
    • A detection in Mode Switch: recorded since last reset
• R Wave Amplitude Distribution
  • Two histograms report the distribution of ventricular wave amplitude measured beat to beat.
  • Graphs report the total number of cycles counted and the programmed sensitivity (red bar) for the Ventricular channel:
    • R waves: recorded since last reset
    • PVC: recorded since last reset

5.2.1.10. Real Time EGM

Provides a 7-second EGM strip automatically recorded during the data transmission from the implanted device to the monitor.

The strip shows Atrial and RV channel EGM records and the associated marker chain.

5.2.1.11. SMARTVIEW HF

The summary graph is composed of several 6 month records synthesized to present a snapshot of the patient's cardiac rhythm. Trends are synchronized in time.

• Atrial Fibrillation (AF)

  Time in Mode switch: Trend of the daily time spent in mode switch by the patient.

• Sleep Apnea

  SAM index: evolution of disrupted respiratory events and status as compared to the severity threshold.

• Heart Rate
  • Heart rate: trends the daily mean values of the atrial rhythm (A) and ventricular rhythm (V)
  • A/V pacing: Trends the ventricular pacing percentage (respectively Atrial), computed with respect to the total number of ventricular cycles (respectively Atrial cycles).

5.2.1.12. SafeR

This section presents:

• The percentage of time spent in AAI
• The number of switches from AAI to DDD on 3rd degree AV block
• The number of switches from AAI to DDD on 2nd degree AV block
• The number of switches from AAI to DDD on 1st degree AV block